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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00475787 |
The purpose of this study is to determine the effectiveness of Chiropractic management for treatment of chronic lower back pain in older adults.
Condition | Intervention |
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Chronic Low Back Pain |
Procedure: Spinal Manipulation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Chiropractic Management of Chronic Lower Back Pain in Older Adults |
Estimated Enrollment: | 216 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
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Procedure: Spinal Manipulation
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
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2: Sham Comparator
Detuned Ultrasound
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Procedure: Spinal Manipulation
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
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The identification of alternative safe and effective interventions for chronic lower back pain in the elderly is critical in view of its high prevalence, negative impact on quality of life and the treatment risks associated with chronic medication use. This is particularly germane to the veteran population, with a prevalence of lower back pain in excess of 40%. In 1998, published guidelines from the American Geriatric Society listed chiropractic management among the non-pharmacologic strategies for treating chronic pain symptoms in older adults. A recent study showed that a substantial number of older patients who received chiropractic care were less likely to be hospitalized, less likely to have used a nursing home, more likely to report a better health status, more likely to exercise vigorously and more likely to be mobile in the community. Patient's undergoing chiropractic care have also reported greater satisfaction as compared to standard medical care. Despite the general clinical acceptance of chiropractic care and satisfaction with chiropractic services, evidence on the potential benefit and safety of chiropractic management of lower back pain in older adults is lacking. The purpose of this study is to evaluate the effectiveness of chiropractic management in older adults with chronic lower back pain, by comparing spinal manipulation to a sham intervention.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Severely demented patients, as indicated by their previous medical history and Mini Mental State scores of 22 or less, will not be selected.
Contact: Dorian Savino, MPA | (585) 463-2673 | dorian.savino@va.gov |
Contact: Pamela J Depuyt, BS | (585) 463-2673 | pamela.depuyt@va.gov |
United States, New York | |
VA Medical Center, Canandaigua | Recruiting |
Canandaigua, New York, United States, 14424 | |
Contact: Dorian Savino, MPA 585-463-2673 dorian.savino@va.gov | |
Contact: Pamela J Depuyt, BS (585) 463-2673 pamela.depuyt@va.gov | |
Principal Investigator: Paul Dougherty, DC | |
VA Western New York Healthcare System at Buffalo | Recruiting |
Buffalo, New York, United States, 14215 | |
Contact: James Lohr, MD 716-862-3204 james.lohr@va.gov |
Principal Investigator: | Paul Dougherty, DC | VA Medical Center, Canandaigua |
Responsible Party: | Department of Veterans Affairs ( Dougherty, Paul - Principal Investigator ) |
Study ID Numbers: | CLIN-011-06F |
Study First Received: | May 17, 2007 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00475787 History of Changes |
Health Authority: | United States: Federal Government |
Older Adults Patient Education Randomized Controlled Trial |
Sham procedure Spinal Manipulation Veterans |
Signs and Symptoms Neurologic Manifestations Low Back Pain Pain Back Pain |
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Low Back Pain Pain Back Pain |